Foresee Pharma advances MAA filing for cancer candidate
Taiwan-based Foresee Pharmaceuticals (TWO: 6576) has announced progress in filing for European approval for its investigational prostate cancer drug.
The company has successfully concluded its scientific advice discussions with German Federal Institute for Drugs and Medical Devices (BfArM) on key regulatory and development issues relating to a Marketing Authorization Application (MAA) submission of FP-001, Leuprolide Mesylate Injectable Suspension (LMIS) 50mg, a six-month depot of leuprolide mesylate for subcutaneous injection.
Foresee has very recently completed a global registration study with FP-001 LMIS 50mg and plans to seek regulatory approvals in the USA and several major European Union countries.
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